TMC278-TiDP6-C215: A Clinical Trial in Treatment Naive HIV-subjects Patients Comparing TMC278 to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors

NCT00543725 | Completed Phase 3 Results DMC

• 2 other identifiers: CR002704TMC278-TIDP6-C215
• Study Type: interventional
• Target: 680
• Locations: 20 countries
• Sites: 82

Brief Summary

The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278 given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily, when combined with a background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors ( investigator choice of ABC/3TC, TDF/FTC or AZT/3TC) in HIV-1 infected patients who have not yet taken any anti-HIV drugs. The following evaluations will be done: antiviral activity, immunologic changes, and viral geno-/phenotype evolution, relationship of Pharmacokinetics (PK) and PK/Pharmacodynamics and Medical resource utilization and treatment adherence.

Conditions

HIV Infections; HIV-1

Keywords

Antiretroviral; HIV-1; AIDS; TMC278-C215; TMC278-TiDP6-C215; Treatment Naive

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 48

  Virological response is defined as confirmed plasma viral load less than (\<) 50 human immunodeficiency virus-1 (HIV-1) (ribonucleic acid \[RNA\]) copies/milliliter (ml) at Week 48. The TLOVR algorithm was used to derive response. Response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Resuppression after confirmed virologic failure was considered as failure. Virologic Failure includes participants who were rebounder (confirmed viral load \>= 50 copies/ml after being responder) or who were never suppressed (no confirmed viral load \<50 copies/ml).

  Week 48

Secondary Outcomes (8)

• Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 48

  Week 48

• Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <50 Copies Per mL) at Week 96

  Week 96

• Number of Participants With Virological Response (Intent-to-Treat - Snapshot, <50 Copies Per mL) at Week 96

  Week 96

• Number of Participants With Virological Response (Observed, <50 Copies/mL) at Last On-Treatment Visit (Post-Week 96).

  Variable, ranging from 3 months up to maximum 18 months for TMC278 and 12 months for Efavirenz

• Number of Participants With Virological Response (Intent-to-Treat - Time to Loss of Virologic Response [TLOVR], <400 Copies Per mL) at Week 48

  Week 48

Study Arms (2)

002

ACTIVE COMPARATOR

efavirenz 600 mg tablet once daily for 96 weeks

Drug: efavirenz

001

EXPERIMENTAL

TMC278 25 mg tablet once daily for 96 weeks

Drug: TMC278

Interventions

TMC278 DRUG

25 mg tablet once daily for 96 weeks

001

efavirenz DRUG

600 mg tablet once daily for 96 weeks

002

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with documented HIV-1 infection
• Patient has never been treated with a therapeutic HIV vaccine or an ARV drug prior to screening
• Patient's HIV-1 plasma viral load at screening is \> 5,000 HIV-1 RNA copies/mL (assayed by RNA PCR standard specimen procedure)
• Patient's virus is sensitive to the 2 nucleoside/nucleotide reverse transcriptase inhibitors chosen for treatment
• Patient agrees not to start ART before the baseline visit
• Patient is HLA-B\*5701 negative in case abacavir is included in the patient's treatment regimen.

You may not qualify if:

• Previous use of ANY ARV drug for ANY length of time
• Any documented evidence of NNRTI resistance associated mutations in patient's HIV
• Category C AIDS defining illness, except, Stable Kaposi Sarcoma Wasting syndrome if not progressive
• Pneumocystis carinii pneumonia (PCP) that is considered not cured
• Active TB
• Allergy or hypersensitivity to study or background ARTs
• Specific grade 3 or 4 toxicity
• Kidney impairment: calculated creatinine clearance \<50 ml/min

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

Study Sites (82)

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Long Beach, California, United States

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Los Angeles, California, United States

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San Francisco, California, United States

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Washington D.C., District of Columbia, United States

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Atlantis, Florida, United States

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Miami, Florida, United States

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Miami Beach, Florida, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

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Chicago, Illinois, United States

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Lexington, Kentucky, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Springfield, Massachusetts, United States

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Detroit, Michigan, United States

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Minneapolis, Minnesota, United States

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Newark, New Jersey, United States

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Flushing, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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The Bronx, New York, United States

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Philadelphia, Pennsylvania, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Longview, Texas, United States

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Darlinghurst, Australia

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Prahran, Australia

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Surry Hills, Australia

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Antwerp, Belgium

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Brussels, Belgium

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Ghent, Belgium

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Leuven, Belgium

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Campinas, Brazil

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Distrito Barao Geraldo-Campina, Brazil

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Pinheiros, Brazil

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Recife, Brazil

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São Paulo, Brazil

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Calgary, Alberta, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Providencia, Chile

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Santiago, Chile

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Beijing, China

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Guangzhou, China

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Shanghai, China

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San José, Costa Rica

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Clamart, France

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Le Kremlin-Bicêtre, France

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Montpellier, France

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Paris, France

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Berlin, Germany

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Cologne, Germany

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Essen, Germany

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Frankfurt, Germany

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Hamburg, Germany

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Hanover, Germany

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Mannheim, Germany

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Chennai, India

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Nagpur, India

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Guadalajara, Mexico

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Mexico City, Mexico

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Panama City, Panama

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Porto, Portugal

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San Juan, Puerto Rico

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Moscow, Russia

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Saint Petersburg, Russia

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Smolensk, Russia

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Voronezh, Russia

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Bloemfontein, South Africa

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Cape Town, South Africa

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Dundee, South Africa

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Johannesburg, South Africa

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Pretoria, South Africa

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Westdene Johannesburg Gauteng, South Africa

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Barcelona, Spain

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Elche, Spain

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Madrid, Spain

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Bangkok, Thailand

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London, United Kingdom

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Manchester, United Kingdom

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Related Publications (3)

• Rimsky L, Van Eygen V, Hoogstoel A, Stevens M, Boven K, Picchio G, Vingerhoets J. 96-Week resistance analyses of rilpivirine in treatment-naive, HIV-1-infected adults from the ECHO and THRIVE Phase III trials. Antivir Ther. 2013;18(8):967-77. doi: 10.3851/IMP2636. Epub 2013 May 28.

  PMID: 23714781 DERIVED

• Nelson M, Amaya G, Clumeck N, Arns da Cunha C, Jayaweera D, Junod P, Li T, Tebas P, Stevens M, Buelens A, Vanveggel S, Boven K; ECHO and THRIVE Study Groups. Efficacy and safety of rilpivirine in treatment-naive, HIV-1-infected patients with hepatitis B virus/hepatitis C virus coinfection enrolled in the Phase III randomized, double-blind ECHO and THRIVE trials. J Antimicrob Chemother. 2012 Aug;67(8):2020-8. doi: 10.1093/jac/dks130. Epub 2012 Apr 24.

  PMID: 22532465 DERIVED

• Cohen CJ, Andrade-Villanueva J, Clotet B, Fourie J, Johnson MA, Ruxrungtham K, Wu H, Zorrilla C, Crauwels H, Rimsky LT, Vanveggel S, Boven K; THRIVE study group. Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1 (THRIVE): a phase 3, randomised, non-inferiority trial. Lancet. 2011 Jul 16;378(9787):229-37. doi: 10.1016/S0140-6736(11)60983-5.

  PMID: 21763935 DERIVED

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Rilpivirine; efavirenz

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Leader
• Organization: Janssen Infectious Diseases BVBA

32 14 641418

Study Officials

• Tibotec Pharmaceuticals, Ireland Clinical Trial

  Tibotec Pharmaceuticals, Ireland

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2007
• First Posted: October 15, 2007
• Study Start: June 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: February 1, 2012
• Last Updated: April 1, 2016
• Results First Posted: July 12, 2011

Record last verified: 2016-03

Locations

DE (7); ME (2); FR (4); CL (2); BR (5); BE (4); ES (3); TH (1); ZA (6); GB (2); PT (1); PR (1); US (25); CO (1); CA (5); IN (2); RU (4); PA (1); CN (3); AU (3)